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What Is FDA Compliance?

The Food and Drug Administration (FDA) is an agency of the U.S. federal government. The FDA is responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices, and consumer products that emit radiation. It has the power to establish federal rules and regulations about these products. FDA compliance is the act of following these regulations.

  1. Food

    • The FDA regulates the safety and wholesomeness of food in the United States (except meat and poultry, regulated by the USDA), and also sets requirements for its labeling. It conducts periodic inspections of food producers and processors to determine if they are obeying these regulations. Those that are not can face a range of penalties including being forced to shut down.

    Drugs and Biologics

    • Before a new drug can be developed and released to market, its manufacturer must prove to the FDA that it is safe and effective. To do so it must be developed and tested in accordance with FDA regulations. Drugs that meet these standards are considered FDA approved. There are also many FDA regulations regarding the labeling and marketing of drugs. Biologics---such as vaccines---are subject to similar regulations.

    Devices

    • The FDA has regulatory authority over medical devices, such as pacemakers, contact lenses, and breast implants. In addition it regulates some radiation emitting consumer devices, including microwaves, x-ray machines, and cell phones. For products like these the FDA sets product safety standards that manufacturers are required to follow. Products which are found not to be in compliance can be declared defective and recalled form the market.

    Limits of FDA Compliance

    • Consumers should be careful not to misunderstand the meaning of FDA compliance or approval. A drug that has been approved for one purpose, for example treatment of back pain, may not be effective at treating other conditions for which it has not been approved, such as treatment of stomach pain.

    Dietary Supplements

    • Dietary supplements, also called herbal supplements, are an example of the complexities of FDA regulations. By law they are treated more like food than like drugs. They do not require FDA approval before being sold. The FDA does regulate the labeling of dietary supplements. Their ingredients must be listed on the label, and they cannot be marketed as being a proven treatment for a condition. Thus dietary supplements can be FDA compliant even though they are not FDA approved.

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